The U.S. Pharmacopeial Convention (USP) Scientist II BioAnalytical in Hyderabad, India
Brief Job Overview
This is a hands-on position in USP-India’s Biologics laboratory in which the incumbent is responsible for delivering laboratory projects by independently contributing in execution of laboratory experiments, project documentation and managing laboratory activities. Deep domain scientific knowledge and laboratory experience in analysis of Biologics is required to contribute in development of reference standards, documentary standards and new initiatives for Biologics product classes such as therapeutic proteins, monoclonal antibodies, vaccines, and peptides using USP’s standard setting processes.
How will YOU create impact here at USP?
Aligns with USP’s mission, goals and objectives and complies with USP’s guidelines and other requirements.
Demonstrates laboratory skills and hands on expertise in analytical Chromatography (HPLC/UPLC with PDA/IR/FLR etc, Ion-chromatography), Electrophoresis, Biochemical assays (SDS-PAGE, Western blot, IEF) and Enzymatic/Protein assays (Spectrophotometer and Plate readers).
Plans and executes Compendial and R&D projects besides contributing in the new initiatives , proof of concept studies in Biologics for product classes such as proteins, enzymes, vaccines, monoclonal antibodies, peptides, antibiotics, and any other biological products as assigned.
Evaluates and analyzes scientific reports, applies personal experience, academic training, and technical insights to troubleshoot and solve problems in the laboratory within the scope.
Performs administrative responsibilities, mentors and trains team member/members as assigned.
Actively engages in project coordination with cross-functional/global teams and aligns with Global Biologics objectives.
Prepares and reviews project reports, SOPs, and other documents to ensure compliance to USP’s Quality Management System and contribute in ISO 9001 and ISO 17025 audits
Assists and recommends improvements in laboratory/project management methods and processes.
Performs other duties as assigned.
Who USP is Looking For?
The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:
MSc./M.Tech./M.Pharm. in relevant stream of Biological Sciences with 4-6 years of industry experience working in Analytical R&D/QC department of Biopharmaceutical industry.
Practical hands-on experience on analytical characterization for biotherapeutics and vaccines using advanced techniques such as Chromatography with multiple detectors, Capillary Electrophoresis (SCIEX/Maurice), Biochemical assays (SDS-PAGE, Western blot, IEF) and Enzymatic/Protein assays (Spectrophotometer and Plate readers).
The candidate should be well-versed with operation and troubleshooting of all instruments used in performing the above-mentioned analytical techniques and should have sound knowledge of QMS systems.
The candidate should have strong competencies in technical writing, communication, and presentation skills.
Additional Desired Preferences
Experience in other advanced analytical techniques such as Mass spectrometry, Circular dichroism, MALS, Differential scanning calorimetry would be an advantage.
Previous experience working in biopharma cGLP/cGMP/QMS environment with practical experience in good documentation practices and knowledge on biopharmaceutical reference standards is a plus.
USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing is protected.
COVID-19 Vaccination Policy (will apply to the selected candidate(s) hired):
As a condition of employment with the United States Pharmacopeial Convention's (USP) duty to provide and maintain a workplace free of known hazards, all employees and contingent staff hired after July 1st, 2021, must be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.
USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our work—from the standards we make to the partnerships and conversations we cultivate. An environment where every employee feels fully empowered and valued irrespective of, but not limited to, personality, race, ethnicity, physical and mental abilities, education, religion, gender identity and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.
Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.
Job Category Chemistry & Scientific Standards
Job Type Full-Time